Federal Preemption Claims: Clear Evidence And An Unclear Standard

Last week, a federal court in Utah granted Aventis Inc.'s motion for summary judgment based on federal preemption of failure-to-warn claims. Cerveny v. Aventis, Inc., 2016 U.S. Dist. LEXIS 34182 (D. Utah Mar. 16, 2016). The court found that the FDA's rejection of additional warnings and consistent approval of labeling contrary to plaintiff's demands constituted "clear evidence" of a conflict between federal and state law, and therefore served as grounds for preemption.

Background

Plaintiff Victoria Cerveny was prescribed and used Clomid in 1992. Following her Clomid use, Mrs. Cerveny became pregnant and gave birth to a son, who was missing two fingers and had a congenital dislocation of the left radial head on his left elbow. The Cervenys alleged that the defects were caused by the residual Clomid in Mrs. Cerveny's body during conception and organogenesis, and that Aventis breached its duty to warn of potential birth defects associated with Clomid use